Cosmetovigilance Services-- ACPL’s Cosmetovigilance Services – Ensuring Regulatory Compliance & Consumer Safety With the rapid growth of the global cosmetic and personal care industry, regulatory bodies worldwide have strengthened cosmetovigilance requirements to ensure product safety and consumer protection. Cosmetovigilance is the post-market monitoring of adverse events (AEs) and undesirable effects (UEs) linked to cosmetic products, ensuring compliance with regulatory standards across different regions. Our Cosmetovigilance Services support cosmetic manufacturers, distributors, and regulatory teams in tracking, analyzing, and reporting product-related safety concerns while complying with ICH, US FDA, EMA (Europe), Health Canada, Australia, GCC, and India regulations. Regulatory Framework for Cosmetovigilance Cosmetovigilance regulations vary across different markets, but all focus on safety assessment, adverse event reporting, and regulatory compliance. Our services align with: ✅ ICH (International Council for Harmonisation) Guidelines – Global framework for safety monitoring ✅ US FDA (Food and Drug Administration) – 21 CFR Part 740 & MoCRA (Modernization of Cosmetics Regulation Act, 2022) ✅ EMA (European Medicines Agency) & EU Cosmetics Regulation (EC) No. 1223/2009 ✅ Health Canada – Food and Drugs Act & Cosmetic Regulations ✅ Australia – NICNAS (National Industrial Chemicals Notification & Assessment Scheme) & TGA (Therapeutic Goods Administration) Compliance ✅ GCC (Saudi FDA, UAE MOH, Qatar Ministry of Public Health) – Regional regulations for cosmetics safety ✅ BIS & CDSCO – Bureau of Indian Standards & Central Drugs Standard Control Organization (India) ACPL’s Comprehensive Cosmetovigilance Services Adverse Event (AE) & Undesirable Effect (UE) Reporting ✔️ Real-time tracking of adverse reactions from cosmetic products ✔️ Consumer complaint handling & analysis ✔️ Periodic reporting & risk-benefit assessment Post-Market Surveillance & Risk Management ✔️ Safety signal detection and trend analysis ✔️ Case processing & pharmacovigilance reporting for borderline products ✔️ Periodic Safety Update Reports (PSURs) & Periodic Benefit-Risk Evaluation Reports (PBRERs) Compliance with Global Regulatory Requirements ✔️ EU Product Information File (PIF) & Responsible Person (RP) support ✔️ US FDA Mandatory Adverse Event Reporting under MoCRA 2022 ✔️ Health Canada’s Incident Reporting & Compliance with NICNAS (Australia) Toxicological Risk Assessments & Ingredient Safety Evaluations ✔️ Safety data analysis for cosmetic ingredients ✔️ Assessment of allergens, preservatives, and banned substances ✔️ Endocrine disruptor & carcinogenic potential evaluation Labeling Compliance & Claims Substantiation ✔️ Validation of cosmetic claims (e.g., “hypoallergenic, ” “dermatologically tested”) ✔️ Compliance with regulatory labelling standards ✔️ Advertising and marketing review for false claims prevention Consumer Safety & Product Recall Management ✔️ Post-market surveillance for high-risk cosmetic products ✔️ Regulatory guidance on product recalls & corrective actions ✔️ Coordination with regulatory authorities for crisis management Clinical & Dermatological Safety Studies ✔️ In vivo & in vitro safety evaluations for cosmetics & personal care products ✔️ Irritation & sensitization studies (Patch tests, HRIPT, Eye irritation tests) ✔️ Efficacy & human-use trials for dermatological safety. For more information visit - https://acplgroupindia.co.in Call – 9266665201 info@acplgroupindia.co.in